Prescription drug · ANDA
Nebivolol NDC 50090-5761
Nebivolol hydrochloride 10 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-5761-0 | 50090576100 | 30 TABLET in 1 BOTTLE (50090-5761-0)Marketed from Oct 1, 2021 | |
| 50090-5761-2 | 50090576102 | 90 TABLET in 1 BOTTLE (50090-5761-2)Marketed from Oct 7, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Nebivolol
- Generic name (nonproprietary)
- nebivolol
- Active ingredients
- Nebivolol hydrochloride — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203828
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 50090-5761_26df2438-2d17-4683-b43d-68e6605495b3SPL ID 26df2438-2d17-4683-b43d-68e6605495b3SPL set ID cdd7a3c5-d3dd-4a89-97d7-642f96eda21bRxCUI 751612UNII JGS34J7L9I
- Pharmacologic class
- beta-Adrenergic Blocker
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450090576100followed by a unit qualifier and the quantityPackage 50090-5761-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Nebivolol is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) 1.1 Hypertension Nebivolol tablets are indicated for the treatment of hypertension, to lower blood pressure [ see Clinical Studies ( 14.1 )]. Nebivolol tablets may be used alone or in combination with other antihypertensive agents [ see Drug Interactions ( 7 )]. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trial…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203828
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Nebivolol | Nebivolol hydrochloride 2.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-5708 |
| Nebivolol | Nebivolol hydrochloride 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3527 |
| Nebivolol | Nebivolol hydrochloride 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-5752 |
| Nebivolol | Nebivolol hydrochloride 2.5 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-393 |
| Nebivolol | Nebivolol hydrochloride 20 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-390 |
| Nebivolol | Nebivolol hydrochloride 10 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-391 |
| Nebivolol | Nebivolol hydrochloride 5 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-392 |
| Nebivolol | Nebivolol hydrochloride 5 mg/1 | TabletOral | American Health Packaging | 60687-641 |
| Nebivolol | Nebivolol hydrochloride 10 mg/1 | TabletOral | American Health Packaging | 60687-652 |